RESUMEN
Background: Colorectal cancer (CRC) is an insidious malignancy and the occurrence of chemotherapy resistance and toxicity seriously limits its clinical efficacy. Insect Compound Particle [Chong Yao Fu Fang (CYFF)] is a traditional Chinese medicine (TCM) compound based on the concepts of "invigorating spleen for strengthening vital qi" and "collateral disease theory". In long-term clinical application, it can reduce the toxicity of CRC chemotherapy and improve the anti-tumor effect. However, there is currently a lack of high-quality clinical evidence to prove the clinical efficacy and safety of CYFF in the treatment of CRC. Methods: We plan to include 262 patients with locally advanced stage III CRC who had undergone surgery and achieved R0 resection. These patients will be randomized into a CYFF group (treated with CYFF combined with chemotherapy) and a control group (treated with placebo plus chemotherapy) at a 1:1 ratio. The patients were routinely followed-up every 2 weeks within 2 months and every 4 weeks after 2 months after the treatment, every 3 months within 1 year, and every 6 months after 1 year. The primary endpoint is disease-free survival (DFS), defined as the time from random assignment to recurrence of primary CRC or death from any cause. The secondary endpoints include overall survival (OS) (defined as the time from randomization to death from any cause), safety [any adverse events (AEs)], and the Colorectal Cancer-Specific Quality of Life Questionnaire (QLQ-CR38) score. Conclusions: Compared with previous studies, our current study applies CYFF plus basic adjuvant chemotherapy, which is expected to achieve better efficacy and longer survival than standard chemotherapy, and reduce the toxic and side effects of chemotherapy, improve the safety of clinical treatment. In addition, our present study is the first clinical study to evaluate the safety and efficacy of CYFF in combination with chemotherapy in the treatment of stage III CRC after R0 resection. Trial Registration: This clinical trial has been registered in the Chinese Clinical Trial Registry (ChiCTR) (registration No. ChiCTR2000037568; August 28, 2020).
RESUMEN
BACKGROUND: Oral capecitabine (CAP) has shown significant benefits in early stage breast cancer (BC). Herein we evaluated CAP as adjuvant monotherapy in women 55 years of age or older with stage IIa BC. PATIENTS AND METHODS: Women with stage IIa BC received 6 cycles of either CAP or CEF (cyclophosphamide/epirubicin/5-fluorouracil) after surgery. The primary endpoint was overall survival (OS). Quality of life (QOL), patient acceptance of chemotherapy, and safety were secondary endpoints. RESULTS: A total of 71 women were enrolled. The 3- and 5-year OS rates were 96.97 and 93.33%, respectively in the CAP group versus 96.67 and 90.32%, respectively in the CEF group. The incidence of disease recurrence or metastasis was 6.67 versus 6.45%, respectively. All CAP patients completed the planned 6 cycles, while only 84% of CEF patients completed all 6 cycles. Myelosuppression, hepatic toxicity, and cardiovascular toxicity were more common with CEF, while hand-foot syndrome was more common with CAP. QOL was significantly better in the CAP group (p < 0.01). Compared with the CEF group, CAP patients had less moderate-to-severe mental disturbance (p < 0.01). CONCLUSIONS: Our results suggest that CAP monotherapy is a potential alternative to CEF adjuvant chemotherapy in patients 55 years old or older with stage IIa BC.